For CDMO and CMO qualification
Qualify a CDMO on what FDA found, not on what they tell you.
Search a contract manufacturer by name or FEI number and read every Form 483, warning letter and close-out for the site.
Screen risk at the site level.
One company can run many plants. The FEI number keeps each site's record apart, so you audit the plant that will actually make your product.
See if problems come back
Compare observations across inspections to judge whether corrective actions held.
Know if it escalated
Did a 483 turn into a warning letter? Was it closed out? The sequence matters.
Plan the audit
Go straight to the systems FDA keeps citing: the laboratory, the quality unit or the cleanroom.
Charts from the record of Matrix Pharmacorp Private Limited, Vizianagaram, India.
Watch every CDMO, then pull the file
Keep an eye on all your contract manufacturers from your AI tools, and put the complete record of one site in the supplier file when it matters.
AI connector · best fit
Ask in Claude or ChatGPT
Ask Claude or ChatGPT for any CDMO's current FDA standing by name or FEI: last inspection and outcome, warning letters, import alerts and recalls, with the documents linked.
From $78/month, billed yearly
See the AI connectorSite file
A site's complete file
Before you sign or renew, buy every document we hold for the site in one order, with bulk pricing, for the quality agreement and audit file.
Bulk pricing in one order
See how site files workPrefer a REST API? See the API.
A warning letter at your CDMO is a problem for your product.
Read the record before you sign the quality agreement.
How teams vet a CDMO
Find the site
Search by CDMO name or FEI number.
Read the history
Follow the site's 483s, letters and responses in date order.
Bring the evidence
Attach the documents to your supplier file and audit plan.
A real site file
Here is the record we hold for Matrix Pharmacorp Private Limited in Vizianagaram, India: every document for the site in one order, with bulk pricing up to 25% off.
Matrix Pharmacorp Private Limited · complete file
4 documents
2 Form 483s1 warning letter1 close-out letter
$396
Questions
Is a Form 483 enough to disqualify a CDMO?
Usually not on its own. A Form 483 lists observations and is not a final agency decision. Read it with any response and later records, such as warning letters or close-out letters, then weigh the risk to your product.
How do I check for repeat observations at a supplier site?
Search the site by FEI number and read its documents in date order. Look for the same theme across inspections and whether later records show it closed. Repeat findings usually matter more than one isolated observation.
What is the difference between a Form 483 and a warning letter?
A Form 483 lists observations at the end of an inspection. A warning letter is a later, formal notice from FDA of significant violations. Treat them as different levels of risk.
Do I get an invoice?
Yes. Every order comes with an invoice PDF, and you can download the whole order as one ZIP file.